DRW Medical NAPA LP-15 User manual

NAPA™LP-15
AIRWAY PRESSURE MONITOR
User’s Manual

Copyright © DRW Medical, LLC
All rights reserved.
DRW Medical, LLC
2710 Concord Road
Aston, PA 19014
Phone: [phone]
www.drwmedical.com

NAPA LP-15 AIRWAY PRESSURE
MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
P/N 13005-S, Rev. 9, 5/12/20
Table of Contents
Table of Contents........................................................................3
1. General Information...........................................................7
1.1 About This Manual.....................................................7
1.2 Manufacturer Information .........................................7
1.3 Classification ..............................................................7
2. Safety Information .............................................................8
2.1 Safety Warnings .........................................................8
2.2 Safety Notes............................................................. 11
3. Intended Use ....................................................................12
3.1 Indications for Use ................................................... 12
3.2 Contraindications..................................................... 12
3.3 Essential Performance..............................................13
4. Introduction –Functional Description .............................. 13
4.1 Principles of Operation............................................. 13
5. Controls, Displays, and Indicators..................................... 16
5.1 NAPA LP-15 Airway Pressure Monitor Front Panel ... 16
5.2 NAPA LP-15 Airway Pressure Monitor Side Panel.....19
5.3 NAPA LP-15 Airway Pressure Monitor Rear Panel .... 19
5.4 Symbols Used on the Monitor.................................. 20
5.5 Symbols Used on the Monitor Label and Packaging . 21

NAPA LP-15 AIRWAY PRESSURE
MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
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6. Setup and Operation.........................................................23
6.1 Connecting the NAPA LP-15 Airway Pressure Monitor
to AC Mains Power................................................................23
6.2 Attaching LP-15 to Pole Mount.................................24
6.3 Normal Operation of the NAPA LP-15 Airway Pressure
Monitor (FIGURE 8) ...............................................................26
6.4 Connecting the NAPA LP-15 Airway Pressure Monitor
to the Patient Circuit (FIGURE 9) ...........................................27
6.5 Full BCPAP System with NAPA LP-15 Airway Pressure
Monitor Schematic................................................................30
7. Alarms and Alarm Limits ...................................................31
7.1 NAPA LP-15 Airway Pressure Monitor Alarms
Overview...............................................................................31
7.2 Alarm Condition Types .............................................32
7.3 Alarm Delay..............................................................32
7.4 Alarm Limits .............................................................33
7.5 When an Alarm is Active: Operator Actions:.............33
7.6 Adjusting Alarm Settings (FIGURE 12).......................34
7.7 Alarm Suspend .........................................................35
7.8 Alarm Settings and Power Interruption ....................35
7.9 Alarm Verification.....................................................35
8. Performance Check...........................................................36

NAPA LP-15 AIRWAY PRESSURE
MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
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8.1 Zeroing the Pressure Sensor (All Users)....................36
8.2 Functional Test (All Users) (FIGURE 13) ....................38
8.3 Monitor Pressure Accuracy Check (Biomedical
Engineer User) (FIGURE 14)................................................... 40
9. Maintenance ....................................................................42
9.1 Cleaning the NAPA LP-15 Airway Pressure Monitor.42
9.2 Troubleshooting.......................................................44
9.3 Gain Calibration (Performed only by Manufacturer) 45
9.4 NAPA Airway Pressure Monitor DC Power Supply.. 456
10. Catalog Item Numbers: NAPA LP-15 Airway Pressure
Monitor Parts & Accessories List...............................................47
11. Product Specifications .................................................. 48
12. Customer Service and Product Support ........................50
13. Electromagnetic Compatibility ..................................... 51
13.1 EMC Overview..........................................................51
13.2 EMC Declaration.......................................................53

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MONITOR USER MANUAL
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MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
P/N 13005-S, Rev. 9, 5/12/20
1. General Information
1.1 About This Manual
This user’s manual has been prepared to provide information
on the correct operation of the NAPA LP-15 Airway Pressure
Monitor. It contains performance specifications, installation,
operation and maintenance information.
This manual is intended for trained health-care
professionals. The NAPA LP-15 Airway Pressure
Monitor may only be used by clinically trained
operators with sufficient knowledge, training and
understanding of this user’s manual. The device
must only be used for the purposes described.
1.2 Manufacturer Information
Manufacturer: DRW Medical, LLC
Address: 811 Lincoln Dr., Brookhaven, PA 19015 USA
Telephone: [phone]
Website: www.drwmedical.com
1.3 Classification
This equipment is classified as protection Class II, type BF in
accordance with IEC 60601-1.

NAPA LP-15 AIRWAY PRESSURE
MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
P/N 13005-S, Rev. 9, 5/12/20
2. Safety Information
2.1 Safety Warnings
Warnings are identified by the WARNING
symbol shown to the left.
Warnings alert you to potential serious
outcomes (death, injury, or adverse events) to the patient or
user, or system damage, if the relevant safety measures are
not observed.
General
•The NAPA LP-15 Airway Pressure Monitor is intended
for use by clinicians with training using airway
pressure monitoring devices.
•The NAPA LP-15 Airway Pressure Monitor is not a life
monitor and an attendant is needed at all times to
monitor the patient.
•Do not adjust alarm threshold parameters so widely
as to render the alarms useless.
•Only use the NAPA LP-15 Airway Pressure Monitor
with its intended patient population and application
–use on other patient types or modes of respiratory
support is not defined and may have unpredictable
functions.
•The NAPA LP-15 Airway Pressure Monitor is not
designed to measure patient respiratory cycles nor
to provide alarms for high or low pressure excursions

NAPA LP-15 AIRWAY PRESSURE
MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
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related to the respiratory cycle. The device measures
and displays a two-second mean (average) airway
pressure for the specified intended application,
neonatal bubble CPAP. The device high and low
alarm thresholds respond to that two second mean
and not to changes within the respiratory cycle.
•The NAPA LP-15 Airway Pressure Monitor does not
display peak or real time airway pressures, and is not
intended to be used with a ventilator.
Safety and EMC
•Do not use oil or grease on the NAPA LP-15 Airway
Pressure Monitor for any reason.
•Do not use the NAPA LP-15 Airway Pressure Monitor
near open flames.
•The internal gas path in the NAPA LP-15 Airway
Pressure Monitor has been tested against leaks to
provide protection during use with enriched Oxygen
CPAP treatment –follow appropriate precautions
whenever sources of enriched Oxygen are used.
•Do not attempt to dismantle or to remove
components since tampering with the NAPA LP-15
Airway Pressure Monitor may cause the unit to
malfunction and will automatically void the
warranty.
•Do not use in the presence of flammable anesthetics
as this may constitute a fire or explosion hazard.
•To avoid personal injury or equipment damage, keep
the power supply cable out of the way of users.

NAPA LP-15 AIRWAY PRESSURE
MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
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•Use the NAPA LP-15 Airway Pressure Monitor only
with its original power supply (Catalog Number
51002).
•The use of portable and mobile radio frequency (RF)
communications equipment can affect this and other
pieces of medical equipment.
•The use of accessories, power sources and cables
other than those specified by DRW Medical may
result in inaccurate readings of the device and
increased emissions or decreased electromagnetic
immunity of the device.
•The NAPA LP-15 Airway Pressure Monitor should not
be used adjacent to or stacked with other
equipment; if adjacent or stacked use is necessary,
the equipment should be observed to verify normal
operation in the configuration in which it will be
used.
•Always ensure that the NAPA LP-15 Airway Pressure
Monitor, its pole mount, and the IV pole are secured
near the patient to prevent unwanted movement of
the system.
•The NAPA LP-15 Airway Pressure Monitor should
always be used on its pole mount –improper or
insecure mounting of the device can allow unwanted
movement of the monitor.
•Caution: In order to minimize problems with
condensation or moisture, the monitored patient
connection point should be at least 25 cm (10 in.)
lower than the unit.
•Do not connect the NAPA LP-15 Airway Pressure
Monitor to a source of airway pressure other than
CPAP pressure –excessive pressure can damage the
unit’s pressure sensor.